FDA Registration
Active
🇰🇷 South Korea
Ti Base Detector
Reg #: 3030089802
·
FEI: 3030089802
·
Expires 2025
Products
1
Proprietary Names
377
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MegaGen Implant Co., Ltd. (Research Laboratories)
- Registration Number
- 3030089802
- FEI Number
- 3030089802
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19, Alphacity 1-ro 31-gil, Suseong-gu
- City
- Daegu
- Country
- KR
Owner / Operator
- Firm Name
- MEGAGEN IMPLANT CO. LTD
- Operator Number
- 9067358
- Address
- 45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
- City
- Daegu
- State
- KR-NOTA
- Postal Code
- 42921
- Country
- KR
- Correspondent
- Kwang Bum Park
US Agent
- Business Name
- LK Consulting Group USA, Inc.
- Contact Name
- Priscilla Chung
- Address
- 18881 Von Karman Ave STE 160
- City
- Irvine
- State
- CA
- ZIP
- 92612
- Country
- US
- [email protected]
- Phone
- 714 2025789
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2005-03-22 |
Proprietary Names
Ti Base Detector
Grafting Pin
R2 ONE2 GUIDE Kit, MKR2OT3000S
Screw Remover
Kit Case, KARIN2001
Bone Expander
Mushroom
Surgical Kit, KREE
BLUE DIAMOND Surgical Kit, KARO3003
Stent Reamer
Torx Driver
Anatomic Healing Abutment Case, C-AHAO04H
Carrier Handpiece Adapter
AnyRidge Surgical Kit, KARIN3001
Hole Trimmer Set
Cylinder Screw
Surgical Kit, SGEZ3001
AnyOne Surgical Kit, KAOIN3003
Surgical Kit, KREIS
Plastic Abutment
Solid Driver
Core Lift Stopper
Stopper
911 Fixture Removal Kit, KPSFS3000
Surgical Kit Case, SGEZ2001
Multi-Unit Carrier
Ratchet Extension
Slot Driver
Kit Case, KARBP2000
Dense Drill
Anatomic Healing Abutment Case, C-AHAO05H
Bottom Drill
Trephine Stopper
High Speed Bur
Plastic Impression Coping
911 Kit, KPSCS3000
Screw Solver Guide Holder
Direction Indicator
Pilot Drill
Bone Profiler Guide Pin
Surgical Kit, ARPK3000
BLUE DIAMOND Surgical Kit, KARO3001
Intermezzo Kit Case, KINT2000
Surgical Kit, MEK3000
Anatomic Healing Abutment Case, C-AHBD04N
Surgical Kit, KAGTS3000
Anatomic Healing Abutment Case, C-AHAO04N
Abutment Removal Driver
Drill Stopper Jig
AnyOne Bone Profiler Kit, KAOBP3000
Kit Case, KAOPK2000
R2 Universal Kit, MKR2U3000L
Reverse Drill
Strong Wrench
Anatomic Healing Abutment Case, C-AHAR07H
Open End Wrench
Retentive Cap
Anchor Kit, KAGAS3001
Anatomic Healing Abutment Case, C-AHBD07N
Surgical Kit, SGTI3000
Implant Carrier
CobraCobra Type
AnyGuide R2 Surgical Kit, KAGIN3000
Surgical Kit, SGEZ3000
Fixture Driver
AnyGuide R2 Kit Case, KAGIN2001
Anatomic Healing Abutment Case, C-AHAO07H
DUO Surgical Kit, MKBDAO3000L
Torx Tip
Double Blade Holder
BonEx Kit, KBECS3000
Seating Rod
Hex Remover
Window Opener
Guide Pin
Anchor Pin
Surgical Kit, MKAO3000M
MegGyver Simple Kit, KMGS3000
Milling Screw
Screw Tapping Driver
DUO Surgical Kit, KBDST3000
B.I.C Carrier
Implant Remover Screw
Impression Coping
Sinus Lift
Plastic Cylinder
Lindermann Drill
MILA Kit, KLSCN3000
Anatomic Healing Abutment Case, C-AHAR04H
Tissue Punch
Screw Solver
Surgical Kit Case, KARO2003
EZ Seal Plus
Retentive Cap Removal Tool
Trox Driver
Surgical Kit Plastic Case, PET2000
EZ Post Guide
Surgical Guide
R2 Universal Kit, KAGUN3000
Lab Analog (Pin Type)
Handpiece Adapter
Intermezzo Drill
BLUEDIAMOND Bone Profiler Kit, KAROBP3000
Multi Prosthetic Kit, KEZP3000
Analog
Hand Driver
Mushroom Type
Flattening Drill Housing
Surgical Kit, MKARI3000M
Depth Gauge
Surgical Kit, MKBD3000L
Surgical Kit, KSDCS3000
Surgical Kit, SGRE3000
Short Implant Solution Kit Case, KMXIS2000
Tip Driver
Cortical Bone Drill
Short Implant Solution Kit, KMXIS3000
Trox Tip
Splitter 2
Square Driver
Tap
AI Surgical Kit, KAISS3000
Kit Case, KANASG2000
Housing Positioner
Twist Drill
Analog Connector
B.I.C Guide Pin
Surgical Kit, MKSI3000M
Surgical Kit, MKAR3000L
Octa Driver
Surgical Kit, SGSM3000
Try-In Abutment
Straight Drill
Cortical Drill
Spreader & Condenser
Stainless Impression Coping
Surgical Kit Case, ARPK2000
Bite Impression Coping
Kit Case, R2SK2000
Lance Drill
Center PinCheckup Pin
Surgical Kit Case, SG1SD1000
Stopper Drill
Reamer Handle
Surgical Kit, MKWD3000M
Surgical Kit, MKAI3000S
Sinus Elevator
Implant Tapping Remover
S.H.A Carrier
Connection Repair Tool
Surgical Kit Case, KAOSS2000
BLUEDIAMOND R2 GUIDE Kit, KAGIN3002
Membrane Elevator001
Surgical Kit, KINT3000
Surgical Kit Case, SGEI2000
EZ Draw
Surgical Kit, KREES
Crown Screw Receiver
Bone Profiler Guide Pin Jig
Bone Calipers
Multi Tool
Torque Wrench Adapter
Tap Drill
Tissue Punches
Kit Case, KAOIN2003
Stopper Holder Jig
Surgical Kit, MKSD3000S
Surgical Kit Case, SGEE2000
AnyGuide R2 Kit Case, KAGIN2000
Surgical Kit Case, KAOSS1000
Bone Profiler
Kit Case, KPSCS2000
AnyGuide R2 Surgical Kit, R2SK3001
Mount Removal Driver
Abutment Remover
Lateral Sinus Kit Case, KLSCN2000
MiNi Kit, KOPSM3003
Kit Case, KSTIN2000
Analog Screw
Marking Drill
R2 Sinus Kit, R2SK3003
Prosthetic Kit, MPK3000
Initial Drill
Torque Wrench
Reamer Drill
Trephine Stopper Jig
Anchor Kit, KAGAS3000
Auto-Max Kit, KAMS3000
Surgical Kit, SGPM3000
Handpiece Connector
Lindermann Bur
Impression Driver
MiNi Kit, KOPSM3001
Stent Anchor
BLUEDIAMOND R2 GUIDE Kit Case, KAGIN2002
Screw Remover Guide Holder
Stainless Steel Housing
Scan Post
Surgical Kit, KRSEN2000
Surgical Kit, SGEI3000
Anatomic Healing Abutment Case, C-AHAO07N
Surgical Kit, KEXEN2000
Hole Trimmer
Path Finder
AnyGuide Kit (AnyRigde Internal), KARIF3000
Test Pin
Abutment Screw
AnyGuide R2 Surgical Kit, MKR2O3000L
Surgical Kit, MKBD3000M
DUO Surgical Kit, MKBDST3000L
Surgical Kit, MKAR3000M
DUO Surgical Kit, MKBDAR3000L
Profile Drill
Flattening Lance
Scan Post Carrier
Implant Mount Screw
Open Wrench
Carbide Round Bur
Surgical Kit, KAGIS3000
Lab Analog Socket
Split ChiselSplitter 1
Anatomic Healing Abutment Case, C-AHAR04N
Surgical Kit Case, SGPM2000
Magnetic Positioner
Removal Driver
Membrane Elevator
Bone Splitter 1
Screw Retriever
Scan Bar
Carrier Extension
Abutment Selection Guide Kit, KANASG3000
AnyRidge Prosthetic Kit, KANPK3000
Auto-Max
Surgical Kit Case, KARIN1000
Insert Driver
Reamer Driver Center Pin
AnyGuide R2 Surgical Kit, KAGIN3001
Right Angle Driver
AXA Selection Kit, MKAXSARI3000L
Surgical Kit, AOPK3000
Burn-Out Cylinder
Set-Up Pin
Multi-Unit Driver
AnyRidge Surgical Kit, KARIN3003
Ring Wrench
Right Angle Adapter
Bone Splitter 2
Abutment Solver
Scan Abutment
Surgical Kit, MKST3000M
Bone Carrier
Abutment Remover Housing
AXA Selection Kit, MKAXSBD3000L
Ez Crown Impression Coping
Retractor
Anchor Kit Case, KAGAS3002
Ratchet Connector
Membrane Elevator002
Positioning Cylinder
Protective Disk
Fixture Remover Screw
Kit Case, KAGNS2000
AnyGuide Laboratory Kit, KFGLS3000
AXA Carrier
R2 Narrow Kit, MKR2NR3000M
Easy Crown Analog
AXA Prosthetic Kit, KAXAR3000S
Final DriverFixture Remover
Flattening Drill
MiNi Kit, KOPSM3002
Meg-Rhein Overdenture
Anatomic Healing Abutment Case, C-AHAR07N
Anatomic Healing Abutment Case, C-AHAR05H
Surgical Kit, SGEE3000
Surgical Kit, KARIP3000
AnyOne Prosthetics Kit, KAOPK3000
Anatomic Healing Abutment Case, C-AHBD04O
Prosthetic Kit Case, MPK1000
R2 Narrow Kit, KAGNS3000
Countersink
Kit Case, KAOBP2000
Hex Solver
Surgical Kit, KRSIN2000
RP Analog
Angled Abutment Guide
Try-In Abutment Package
Prosthetic Kit Case, MPK2000
EZ Seal Kit, EZSP23K
Bone Expander Kit Case, KBECS2000
Surgical Kit, SGEZ2000
AnyOne Stopper Drill Kit, KAOSS3000
Screw Solver Guide
MICAkit, SGIS3000
ASBE Trephine
Implant Carrier-Handpiece Type
Kit Case, KARIN2003
Solid Post Driver
Anatomic Healing Abutment Case, C-AHBD05O
Short Drill Kit, MSK3000
Ratchet Wrench
Angle Guide Tool
Guide Sleeve
Diamond Drill
Anatomic Healing Abutment Case, C-AHBD07O
Lab Analog
Narrow Crest Drill
Anchor Kit, KAGAS3002
Second Drill
Laboratory Bur
Removal Guide Pin
Shaping Drill
Bone Tack Carrier
Prosthetic Kit Case, KANPK2000
Fattening Drill Housing
Hand Tap
Multi Post Screw
AnyRidge Bone Profiler Kit, KARBP3000
Surgical Kit, KMIIP3000
Anatomic Healing Abutment Case, C-AHAR05N
Stopper Holder
Point Trephine Bur
Kit Case, KANASG1000
Scan Post (Impression Type)
Stent Sleeve
Drill Extension
Snap Impression Coping
Trephine Bur
AnyGuide R2 Surgical Kit, MKR2R3000L
Surgical Kit, MKAO3000L
Bone Condenser
MegGyver Kit, MKMG3000M
Implant Remover
Scan Abutment Screw
Guide Tube
Trephinb Bur
Express BurExtractor
Initial Guide Drill
Screw Remover Guide
Anatomic Healing Abutment Case, C-AHBD05N
DUO Surgical Kit, KBDAO3000
Surgical Kit, KEXIN2000
Surgical Kit, MIK3000
Retentive Cap Insertion Tool
Torque Driver
Bur Stopper Jig
Anatomic Healing Abutment Case, C-AHAO05N
Multi Prosthetic Kit, KEZPK3000
Surgical Kit Case, SGIS2000
Multi-Unit-Detector Set
Bite Impression Cap
AnyGuide R2 Surgical Kit, MKR2B3000L
CASA Drill
Surgical Kit, MKST3000L
Implant Mount
Reverse Scan
Remover Driver
MegGyver Simple Kit Case, KMGS2000
Manual Inserter Tip
MegGyver Kit Case, MKMG2000M
Implant Driver Pin
Implant Driver Body
Manual Inserter
ZBLC Kit, KZBLCBD3003
MILAkit, MKLA3000M
AXA Prosthetic Kit, KAXBD3000S
Abutment Remover Driver
Implant Driver
MICAkit, MKCA3000S
Reverse Jig Connector
AXA Prosthetic Kit, KAXARI3000S
Ti Base Detector Set
Scan Cap
Angle Guide Pin
Multi-Unit-Detector
AXA Driver
Angle Guide Tool Pin
ZBLC Kit, KZBLCAR3001
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility